510(k) K182542
K182542 is an FDA 510(k) premarket notification submitted by Safeop Surgical, Inc. for the device "The EPAD 2 System". The FDA issued a decision of Substantially Equivalent on February 22, 2019. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Safeop Surgical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 2019
- Date Received
- September 17, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Electrical, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1870
- Review Panel
- NE
- Submission Type